—#34585

Product

ConMed Stealth Coated Laparoscopic Electrodes with 3/32'' pin (60-5158 series) as follows: Cat. #60-5158-027 - Spatula 5 mm x 27 cm; Cat #60-5158-032 - Spatula 5 mm x 32 cm; Cat. #60-5158-044 - Spatula 5 mm x 44 cm; Cat #60-5158-127 - L Hook 5 mm x 27 cm; Cat #60-5158-132 - L Hook, 5 mm x 32 cm; Cat #60-5158-144 - L Hook 5 mm x 44 cm; Cat #60-5158-232 - J Hook 5mm x 32 cm; Cat. #60-5158-244 - J Hook 5mm x 44 cm; Cat #60-5158-927 - Needle 5 mm x 27 cm; Cat #60-5158-932 - Needle 5 mm x 32 cm; Firm on label: ConMed Corporation, Utica, New York 13502.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K960808
Affected lot / code info: Cat #60-5158-027, Lot #s 0309121, 0310301, 0401051, 0404271, 0405031; Cat #60-5158-032, Lot #s 0309011, 0309111, 0401121, 0402031, 0402271, 0404131, 0405031, 0406071; Cat #60-5158-044, Lot #s 0309151, 0403121; Cat #s 60-5158-127, Lot #s 0309021, 0309151, 0310301; Cat #60-5158-132, Lot #s 0308071, 0308211, 0310081, 0311031, 0311101, 0401051, 0402031, 0402271, 0403121, 0404131; Cat #60-5158-144, Lot #s 0308261, 0310061, 0310081, 0311101, 0402031, 0403031, 0403121, 0406071; Cat #s 60-5158-232, Lot #s 0309121, 0310301, 0402181, 0404301; Cat #60-5158-244, Lot #s 0309121, 0310081, 0402271, 0404301; Cat #60-5158-927, Lot # 0309021; Cat # 60-5158-932, Lot #0308111, 0309021, 0310081, 0311101, 0401121, 0402181, 0403121.

Why it was recalled

Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.

Root cause (FDA determination)

Other

Action the firm took

Letters dated 8/9/04 via Priority Mail with instructions to return product and subrecall if further distributed.

Recalling firm

Firm: Conmed Corporation
Address: 525 French Rd, Utica, New York 13502-5945

Distribution

Distribution pattern: There are 127 distributors, hospitals and sales representatives in the U.S. There are 21 foreign consignees in Australia, Brazil, Canada, Costa Rica, Ecuador, Finland, India, Israel, Italy, Norway, Peru, Saudi Arabia, Spain, Turkey, United Kingdom, and Venezuela.

Timeline

Recall initiated: 2004-08-09
Posted by FDA: 2004-08-28
Terminated: 2005-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34585. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.